News

Australia was one of the first countries to approve the use of Mavenclad (cladribine tablets, 10 mg) to treat patients with highly active relapsing-remitting multiple sclerosis (RRMS). Now, the country’s government has taken another step to ensure this 20-day course treatment is available to the largest number possible of people affected by the disease. Australia’s Prime Minister, Hon. Scott Morrison MP, announced that Merck KGaA’s therapy was included on the Pharmaceutical Benefits Scheme (PBS) listing effective Jan. 1. This will make Mavenclad affordable for about 6,200 patients each year who are already accessing PBS-subsidized medicines for MS. (Of note, Merck KGaA is known as EMD Serono in the U.S. and Canada.) This was made possible by the joint effort of MS Australia, MS Research Australia, clinicians and members of the MS community who, after successive submissions, achieved a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to list Mavenclad on PBS as a treatment for RRMS. Australia's government will cover almost all costs of Mavenclad, which will mean that patients will have to pay only $40.30 per prescription, or $6.50 for concessional patients. “Thanks to our strong economic management, we’ve ensured that every new, essential medicine recommended for listing by the Pharmaceutical Benefits Advisory Committee receives government subsidy to make it affordable for all Australians,” the Prime Minister said in a press release. Mavenclad was developed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. To be taken for a maximum of 20 days over two years, the oral drug has shown it helps MS patients remain relapse-free for up to four years, while supporting the “reset” of the immune system. Australia's regulatory agency decided to approve Mavenclad based on the findings of a number of clinical trials, including the Phase 3 CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) studies, as well as the Phase 2 trial ONWARD study (NCT00436826), and the long-term PREMIERE (NCT01013350) trials. These clinical studies involved more than 2,700 RRMS patients, some of whom were followed for more than 10 years. Overall, the trials showed that Mavenclad significantly reduced relapse rates, disability progression, and brain atrophy. Doctors recommend the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments.

A type of immune cell from the gut can reduce brain inflammation in people with multiple sclerosis (MS), and increasing the numbers of these cells in a mouse model of the disease halts inflammation completely, new research reports. These findings were reported in the study, “Recirculating…

Blood infection with the yeast Candida albicans, a type of fungus, can reach the brain and trigger an immune response, a new mouse study shows. Although the fungus can be cleared within 10 days, it affects the spatial memory of mice. These findings are the first evidence that a blood infection with a…

BrainStorm Cell Therapeutics announced that the production of its therapy NurOwn will be expanded to support upcoming clinical trials, namely a Phase 3 trial in amyotrophic lateral sclerosis (ALS) and a Phase 2 trial in progressive multiple sclerosis (MS). BrainStorm’s proprietary, stem cell-based technology called…

Five finalists remain in the running for the $1 million prize being offered in the Mobility Unlimited Challenge, a global competition to promote the development of innovative solutions for personal mobility devices. A panel of expert judges selected the finalists from among 80 applications submitted by teams from 28 countries.

Biogen and Skyhawk Therapeutics have created a strategic partnership that will allow both companies to use Skyhawk’s SkySTAR technology platform for the discovery of new small molecule treatments for neurological diseases, including multiple sclerosis and spinal muscular atrophy. Under the terms of the agreement, Biogen will be given…

Immune cells in the intestine may reduce neuroimflammation in multiple sclerosis (MS) patients, a pre-clinical study suggests. Moreover, the augmented number of these cells was sufficient to suppress brain inflammation in an MS mouse model. The findings were reported in the study “Recirculating Intestinal IgA-Producing Cells Regulate Neuroinflammation via…

Biogen announced the start of a global Phase 3b clinical trial to evaluate the efficacy and safety of extended interval dosing (EID) with Tysabri (natalizumab) in patients with relapsing-remitting multiple sclerosis (RRMS). Results of the six-week dosing interval will be compared with the approved standard interval dosing…

Because multiple sclerosis (MS) presentation and progression course can be very different between people of African ancestry and Caucasians, the recruitment of minorities to Phase 3 clinical trials is of particular importance. Researchers in the MS field and the general MS community should make a greater effort to improve…

Lowering body temperature helps to improve exercise and functional capability in multiple sclerosis (MS) patients by preventing disease worsening, researchers in  Greece report. The study with that finding, “Impact of pre-cooling therapy on the physical performance and functional capacity of multiple sclerosis patients: A systematic review,” was published in…

Banner Life Sciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Bafiertam (monomethyl fumarate), a novel bioequivalent of Biogen’s Tecfidera (dimethyl fumarate) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Final approval is expected no later than…

An altered metabolism and signaling is associated with the ability of a subset of immune T helper 17 (Th17) cells to induce neuroinflammation, according to a new study of mice. The findings may lead to new treatments for multiple sclerosis (MS) and other chronic inflammatory diseases, the scientists said.

Unusually high levels of a transcription factor called paired related homeobox protein 1 (PRRX1) in human oligodendrocyte progenitor cells hinders their ability to respond to the loss of myelin and to transform into mature, myelin-producing oligodendrocytes, a new study shows. These findings suggest a new potential way of treating …

A product called acrolein, which is naturally excreted by the body and possible to measure in urine and blood, may be a potential biomarker to help diagnose and evaluate disease activity in people with multiple sclerosis (MS), according to preliminary research in animal models and humans. Researchers are investigating whether acrolein…

Multiple Sclerosis News Today brought you daily coverage of key findings, treatment developments, and clinical trials related to multiple sclerosis (MS) throughout 2018. We look forward to reporting more news to patients, family members, and caregivers dealing with MS during 2019. Here are the top 10 most-read articles of…

Treatment with autologous hematopoietic stem cell transplant (aHSCT) led to a sustained decrease in disability and almost no clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) who had failed to respond to prior immunosuppressive therapies, an Australian Phase 2 trial shows. Trial findings were published in the study, “Prospective phase…

Multiple sclerosis (MS) patients who reported food allergies showed a 27 percent higher cumulative rate of flare-ups over the course of their disease, and more than twice the likelihood of having active inflammatory lesions, a new study shows. The study, “Food Allergies are Associated with Increased Disease Activity…

A genetic variant associated with an increased risk of multiple sclerosis (MS) due to its impact on certain immune system cells can also affect brain cells called astrocytes, a study shows. Reported in the study, “Enhanced astrocyte responses are driven by a genetic risk allele associated with multiple…

OWC Pharmaceutical Research is planning new clinical studies to evaluate the activity and safety of its cannabinoid-enriched sublingual soluble tablet. The company announced that an Institutional Review Board (IRB) in Israel approved its request to conduct a safety and tolerability trial there. The company also is asking to amend the…

Treatment with Ampyra (dalfampridine) for 24 weeks leads to sustained and clinically meaningful improvements in walking ability as reported by multiple sclerosis (MS) patients with gait difficulties, according to a study analyzing results from a Phase 3 trial. The study, “Assessment of Clinically Meaningful Improvements in Self-Reported…

The U.S. Food and Drug Administration (FDA) has approved BrainStorm Cell Therapeutics‘ request to open a Phase 2 clinical trial testing the safety and effectiveness of its proprietary NurOwn mesenchymal stem cell (MSC) treatment in progressive multiple sclerosis (MS) patients. The request was in the form of Investigational New Drug…

Alkermes filed a request for the approval of diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis (MS) with the U.S. Food and Drug Administration (FDA). If approved, diroximel fumarate will be marketed by Biogen in the U.S., likely under the brand name Vumerity. Alkermes and Biogen are working…

Pretreating multiple sclerosis patients with antihistamines more extensively and with hydration can significantly reduce — by 60% — the likelihood of infusion-associated reactions that are the most common side effect of Ocrevus (ocrelizumab) use, a pilot study reported. Data also found that older and male MS patients are less likely to have…

Inactivation of S1PR2, a cell surface protein, helps improve clinical disability and reduce demyelination in a mouse model of experimental autoimmune encephalitis (EAE), a condition similar to multiple sclerosis (MS) in humans, a study shows. This finding suggests that therapies blocking S1PR2 could have the potential to treat MS. The…

Risk factors often associated with multiple sclerosis (MS), such as genetic background, obesity and smoking, contribute independently to the disease’s variability and may be an early influence on progression, a study reported. The retrospective study, “Multiple sclerosis risk factors contribute to onset heterogeneity,” was published in the journal …

Many multiple sclerosis (MS) patients report that cannabis has beneficial effects on their symptoms with minimal side effects, according to a survey that also showed that varying effects on health may be due to differences in how users consume cannabis. Findings from the survey were reported in the…

Researchers at the Ural Federal University (UrFU) in Russia have developed a neuro-electrostimulation system that has the potential to treat different types of brain disorders, including multiple sclerosis (MS). The system allows physicians to treat patients by remotely controlling the delivered electric pulse through a smartphone or tablet. Details…

Multiple sclerosis (MS) patients who have been relapse-free while using an interferon-beta (IFN-β) therapy but switch to another IFN-β are significantly more like to start experiencing flares than patients who remain on their initial interferon treatment, a real-world study reports. Its results support letting patients remain on a current IFN-β medication…

Lipoic acid (LA), an over-the-counter antioxidant supplement, helps to mildly delay a decline in walking speed in secondary progressive multiple sclerosis (SPMS) patients, particularly those with lesser disability, analysis of a small, two-year clinical study reports. No improvements were seen in balance among…

As debate continues about the effects of medical marijuana on multiple sclerosis (MS) and other diseases, cannabis company GB Sciences and Louisiana State University (LSU) have agreed on a cannabinoid research and development project. This collaboration between a public and a private enterprise is a first in the therapeutic cannabis…